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Aug 31, 2010

Stem Cell Research and Politics at Odds Again

The National Institutes of Health (NIH) issued new guidelines today regarding how it will comply with the recent August 23, 2010, Court ruling issuing an injunction that blocks the use of federal funds for embryonic stem cell (ESC) research in this country.

Judge Royce Lamberth, a Texan conservative appointed by former President Ronald Reagan, sent shock waves through this country’s academic, research and medical sectors last week as he issued a preliminary injunction against further federal funding for ESC research saying it was in violation of the Dickey-Wicker amendment. The Obama administration and the Justice Department have indicated that they will appeal the decision as soon as possible.

The recently announced NIH guidelines indicate that any grants funded on or before August 23, 2010, would not be affected by the ruling and "award recipients may continue to expend the funds awarded to them prior to the date of the injunction."

The Director of NIH, Dr. Francis S. Collins, indicated that "The recent court ruling that halted the federal funding of human embryonic stem cell research could cause irreparable damage and delay potential breakthroughs to improve care for people living with serious diseases and conditions such as spinal cord injury, diabetes, or Parkinson’s disease. The injunction threatens to stop progress in one of the most encouraging areas of biomedical research, just as scientists are gaining momentum—and squander the investment we have already made."

The Dickey-Wicker Amendment is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. HHS funding includes the funding for the NIH. The wording of the rider is generally the same each year and prohibits HHS, including NIH, from using federally appropriated funds as follows:

SEC. 509. (a) None of the funds made available in this Act may be used for--

(1) the creation of a human embryo or embryos for research purposes; or

(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) (Title 42, Section 289g(b), United States Code).

(b) For purposes of this section, the term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations)… that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells).

In March 2009, President Obama issued an executive order that removed the restriction against federal funding of stem cell research, yet the Dickey-Wicker Amendment remains an obstacle for federally funded researchers seeking to create their own stem cell lines. At this point, embryonic stem cell research in this country is frozen in time based on the language added annually to the Federal budget that was drafted at a time when ESC research was in its earliest stages and not envisioned by the authors of that document.

Judge Lamberth’s rationale in his ruling is based in part on interpreting the Dickey-Wicker amendment as applying to all research that destroys an embryo, and not just a “piece of research”. His analysis reasons that "Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo... Congress could have written the statute that way."

In hindsight, yes, if Congress intended that any and all aspects of stem cell research that included the use of any cell that was pluripotent and had anything to do with tissue defined as an “embryo”, the generation or destruction of such an embryo, or any cell that is considered part of or potentially part of an embryo, perhaps they could have written the Dickey-Wicker amendment using clearer and more precise language. However, how can we have expected Congress to anticipate the course of science when even the brightest minds in this country doing scientific research could not have anticipated what the last 15 years have provided in the way of stem cell research and therapeutic applications?

It is hard to believe that one year ago, the scientific community was celebrating President Obama’s ruling overturning the Bush prohibitions on stem cell research. Yet, here we sit today stunned that 12 months of forward scientific momentum is suddenly brought to a screeching halt and the promise of new therapies is becoming an impossibility as each day passes and research cannot continue in our universities and non-profit research centers.

For those that say that adult stem cell research and other stem cell technologies can proceed in the face of this injunction, or that private funding in companies can proceed, keep in mind that ESC research is another piece of the puzzle to curing cancer or helping paralyzed individuals walk again, that cannot be left on the side of the road. All of these distinct stem cell technologies will provide advantages and disadvantages for different patients and different diseases. Why not allow all of this amazing science to move forward with support from our government?

So what now? Some say that Judge Lamberth’s decision could be interpreted so broadly at this point that it would also ban federal funding on the 22 stem cell lines that even Bush had approved. In addition to changing the language of the Dickey-Wicker amendment to meet the current needs of the scientific and medical communities, specific legislation that codifies President Obama’s executive order from 2009 must be enacted, otherwise, we could face additional turmoil once a new administration comes in to office in the future.

Dickey-Wicker was never intended to prevent stem cell research. Do we need to go back and re-define what an “embryo” is in order to avoid application of Dickey-Wicker to all embryonic stem cells? I wonder what Senator Ted Kennedy would be thinking today…

Lisa A. Haile, Ph.D. (lisa.haile@dlapiper.com), is a partner at DLA Piper LLP US and co-chair of the firm’s Global Life Sciences Sector Group. Her practice focuses on strategic counseling relating to all areas of biotechnology and life sciences intellectual property law. Web: www.dlapiper.com/lisa_haile.Twitter: @dnajd.

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